Paclitaxel-Eluting Balloon Versus Standard Balloon Angioplasty in In-Stent Restenosis of the Superficial Femoral and Proximal Popliteal Artery: 1-Year Results of the PACUBA Trial
| Autor: | Christian M, Kinstner, Johannes, Lammer, Andrea, Willfort-Ehringer, Wolfgang, Matzek, Michael, Gschwandtner, Domagoj, Javor, Martin, Funovics, Maria, Schoder, Renate, Koppensteiner, Christian, Loewe, Robin, Ristl, Florian, Wolf |
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| Rok vydání: | 2015 |
| Předmět: |
Male
Time Factors Paclitaxel Kaplan-Meier Estimate Peripheral Arterial Disease Coated Materials Biocompatible Recurrence Risk Factors Odds Ratio Humans Ankle Brachial Index Popliteal Artery Single-Blind Method Prospective Studies Vascular Patency Aged Cardiovascular Agents Equipment Design Middle Aged Femoral Artery Logistic Models Treatment Outcome Austria Multivariate Analysis Retreatment Female Stents Angioplasty Balloon Vascular Access Devices |
| Zdroj: | JACC. Cardiovascular interventions. 9(13) |
| ISSN: | 1876-7605 |
| Popis: | The hypothesis that paclitaxel-eluting balloon angioplasty provides higher 1-year patency rates in femoropopliteal artery in-stent restenosis compared with standard percutaneous transluminal angioplasty (PTA) was tested.Several trials have demonstrated that paclitaxel-eluting balloon angioplasty reduces late luminal loss in comparison with PTA.In a prospective, randomized, single-blind, dual-center study, 74 patients with symptomatic peripheral artery disease due to in-stent restenosis were treated with either paclitaxel-based drug-eluting balloon (DEB) angioplasty (n = 35) or standard PTA (n = 39). Clinical outcomes and patency rates were assessed at 1, 6, and 12 months.The mean lesion length was 17.3 ± 11.3 cm in the DEB group and 18.4 ± 8.8 cm in the PTA group. A single major complication (bleeding) was observed once (1.4%). The mean ankle-brachial index before endovascular treatment was 0.65 ± 0.16 in both groups and 0.79 ± 0.2 versus 0.84 ± 0.3 (p = 0.70, Student t test) in the DEB versus PTA group at 12 months. The 12-month primary patency rates were 40.7% (95% confidence interval [CI]: 0.26 to 0.64) versus 13.4% (95% CI: 0.05 to 0.36) (log-rank p = 0.02) in the DEB versus PTA group. The odds ratio for PTA over DEB angioplasty for experiencing an event was estimated at 2.8 (95% CI: 1.2 to 6.6). Freedom from clinically driven target lesion revascularization was 49.0% (95% CI: 0.32 to 0.75) versus 22.1% (95% CI: 0.10 to 0.48) (log-rank p = 0.11) in the DEB versus PTA group. Clinical improvement by ≥1 Rutherford-Becker category was 68.8% versus 54.5% (p = 0.87) in the DEB versus PTA group at 12 months.When treating peripheral artery disease in patients with in-stent restenosis in the femoropopliteal artery, paclitaxel-eluting balloon angioplasty provides significantly higher patency rates than standard PTA. (Paclitaxel Balloon Versus Standard Balloon in In-Stent Restenoses of the Superficial Femoral Artery [PACUBA I Trial] [PACUBA 1]; NCT01247402). |
| Databáze: | OpenAIRE |
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